XIA 3 48233640Recalls & reported problems

Stryker Corporation · UNIPLANAR SCREW · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327001150), received between May 23, 2017 and May 23, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Device Slipped4
Mechanical Problem3
Disassembly1

Patient problems

No Code Available4
No Known Impact Or Consequence To Patient4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 23, 2017Disassembly; Device Slipped; Disassembly
IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE (B)(6) 2017 THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDOARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDOARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6586526 ↗
MalfunctionMay 23, 2017Mechanical Problem; Device Slipped; Mechanical Problem
IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDOARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDOARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6586509 ↗
MalfunctionMay 23, 2017Mechanical Problem; Device Slipped; Mechanical Problem
IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDOARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDOARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6586504 ↗
MalfunctionMay 23, 2017Mechanical Problem; Device Slipped; Mechanical Problem
IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDOARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDOARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6586503 ↗

Device details

UDI-DI	`07613327001150`
Brand	XIA 3
Model	48233640
Company	Stryker Corporation
Product code	MNI · ORTHOSIS, SPINAL PEDICLE FIXATION
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Other ORTHOSIS, SPINAL PEDICLE FIXATION devices

NA 04.614.508
Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION
277 reports
CREO 1134.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
112 reports
CREO 1119.0010
Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
80 reports
VIPER 186731745
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
43 reports
CD HORIZON® Spinal System 1553201090
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
38 reports
EXPEDIUM 179902000
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
37 reports
CD HORIZON® Spinal System 7540220
Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION
36 reports
EXPEDIUM VERSE 199721640
Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION
35 reports

All ORTHOSIS, SPINAL PEDICLE FIXATION devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page